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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

ABSTRACT: Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP.The primary aim of this study is to determine the relative clinical effectiveness of 1) monodisciplinary chiropractic care and 2) multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed.This paper describes the design of a randomized clinical trial (RCT), with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews, using a semi-structured format, are conducted with patients at the end of the 12-week treatment period and also with providers at the end of the trial.This mixed-methods randomized clinical trial assesses clinical effectiveness, cost-effectiveness, and patients' and providers' perceptions of care, in treating non-acute LBP through evidence-based individualized care delivered by monodisciplinary or multidisciplinary care teams.ClinicalTrials.gov NCT00567333.

SUBMITTER: Westrom KK

PROVIDER: S-EPMC2841162 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

Westrom Kristine K KK Maiers Michele J MJ Evans Roni L RL Bronfort Gert G

Trials 20100308

<h4>Background</h4>Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for ch ...[more]

PMID: 20210996

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Project description:BackgroundLow back pain (LBP) is influenced by interrelated biological, psychological, and social factors, however current back pain management is largely dominated by one-size fits all unimodal treatments. Team based models with multiple provider types from complementary professional disciplines is one way of integrating therapies to address patients' needs more comprehensively.MethodsThis parallel group randomized clinical trial conducted from May 2007 to August 2010 aimed to evaluate the relative clinical effectiveness of 12 weeks of monodisciplinary chiropractic care (CC), versus multidisciplinary integrative care (IC), for adults with sub-acute and chronic LBP. The primary outcome was pain intensity and secondary outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia measured at baseline and 4, 12, 26 and 52 weeks. Linear mixed models were used to analyze outcomes.Results201 participants were enrolled. The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC. The primary analysis found IC to be significantly superior to CC over the 1-year period (P = 0.02). The long-term profile for pain intensity which included data from weeks 4 through 52, showed a significant advantage of 0.5 for IC over CC (95% CI 0.1 to 0.9; P = 0.02; 0 to 10 scale). The short-term profile (weeks 4 to 12) favored IC by 0.4, but was not statistically significant (95% CI - 0.02 to 0.9; P = 0.06). There was also a significant advantage over the long term for IC in some secondary measures (disability, improvement, satisfaction and low back symptom frequency), but not for others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-efficacy, active pain coping, and kinesiophobia). Importantly, no serious adverse events resulted from either of the interventions.ConclusionsParticipants in the IC group tended to have better outcomes than the CC group, however the magnitude of the group differences was relatively small. Given the resources required to successfully implement multidisciplinary integrative care teams, they may not be worthwhile, compared to monodisciplinary approaches like chiropractic care, for treating LBP. Trial registration NCT00567333.

Project description:BACKGROUND: There is considerable clinician and researcher interest in whether the outcomes for patients with low back pain, and the efficiency of the health systems that treat them, can be improved by 'subgrouping research'. Subgrouping research seeks to identify subgroups of people who have clinically important distinctions in their treatment needs or prognoses. Due to a proliferation of research methods and variability in how subgrouping results are interpreted, it is timely to open discussion regarding a conceptual framework for the research designs and statistical methods available for subgrouping studies (a method framework). The aims of this debate article are: (1) to present a method framework to inform the design and evaluation of subgrouping research in low back pain, (2) to describe method options when investigating prognostic effects or subgroup treatment effects, and (3) to discuss the strengths and limitations of research methods suitable for the hypothesis-setting phase of subgroup studies. DISCUSSION: The proposed method framework proposes six phases for studies of subgroups: studies of assessment methods, hypothesis-setting studies, hypothesis-testing studies, narrow validation studies, broad validation studies, and impact analysis studies. This framework extends and relabels a classification system previously proposed by McGinn et al (2000) as suitable for studies of clinical prediction rules. This extended classification, and its descriptive terms, explicitly anchor research findings to the type of evidence each provides. The inclusive nature of the framework invites appropriate consideration of the results of diverse research designs. Method pathways are described for studies designed to test and quantify prognostic effects or subgroup treatment effects, and examples are discussed. The proposed method framework is presented as a roadmap for conversation amongst researchers and clinicians who plan, stage and perform subgrouping research. SUMMARY: This article proposes a research method framework for studies of subgroups in low back pain. Research designs and statistical methods appropriate for sequential phases in this research are discussed, with an emphasis on those suitable for hypothesis-setting studies of subgroups of people seeking care.

Project description:BackgroundAt any one time, one in every five Canadians has low back pain (LBP), and LBP is one of the most common health problems in primary care. Guidelines recommend that imaging not be routinely performed in patients presenting with LBP without signs or symptoms indicating a potential pathological cause. Yet imaging rates remain high for many patients who present without such indications. Inappropriate imaging can lead to inappropriate treatments, results in worse health outcomes and causes harm from unnecessary radiation. There is a need to understand the extent of, and factors contributing to, inappropriate imaging for LBP, and to develop effective strategies that target modifiable barriers and facilitators. The primary study objectives are to determine: 1) The rate of, and factors associated with, inappropriate lumbar spine imaging (x-ray, CT scan and MRI) for people with non-specific LBP presenting to primary care clinicians in Ontario; 2) The barriers and facilitators to reduce inappropriate imaging for LBP in primary care settings.MethodsThe project will comprise an inception cohort study and a concurrent qualitative study. For the cohort study, we will recruit 175 primary care clinicians (50 each from physiotherapy and chiropractic; 75 from family medicine), and 3750 patients with a new episode of LBP who present to these clinicians. Clinicians will collect data in the clinic, and each participant will be tracked for 12 months using Ontario health administrative and self-reported data to measure diagnostic imaging use and other health outcomes. We will assess characteristics of the clinicians, patients and encounters to identify variables associated with inappropriate imaging. In the qualitative study we will conduct in-depth interviews with primary care clinicians and patients.DiscussionThis will be the first Canadian study to accurately document the extent of the overuse of imaging for LBP, and the first worldwide to include data from the main healthcare professions offering primary care for people with LBP. This study will provide robust information about rates of inappropriate imaging for LBP, along with factors associated with, and an understanding of, potential reasons for inappropriate imaging.

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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

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